Recruiting

Hyperpolarized 13C MRI

Sponsor:

UCLA

Code:

NCT06600906

Conditions

Pancreatic Ductal Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Computed tomography (CT)

Magnetic Resonance Imaging (MRI)

Study Details

Brief summary:

This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.

Conditions

Pancreatic Ductal Adenocarcinoma

Metastatic Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Study ID

NCT06600906

Start date

Oct 1, 2024

Status verified date

Nov, 2025

Completion date

Sep 1, 2032

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be 18 years or older.
  • Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).
  • Locally advanced or metastatic disease.
  • At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
  • Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
  • Congestive Heart Failure ≥ Class III.
  • Participants who are pregnant.
  • Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
  • Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.
  • Known hypersensitivity to HP 13C pyruvate or any of its excipients.
  • Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A (HP 13C pyruvate, MRI)

Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.

Cohort B (HP 13C pyruvate, MRI)

Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.

Interventions

Hyperpolarized 13C-Pyruvate

Given intravenously (IV)

Computed tomography (CT)

Undergo CT imaging

Magnetic Resonance Imaging (MRI)

Undergo MRI imaging

Primary outcome measure

  • Proportion of participants with best objective response (Cohorts A and B) [ Time Frame: Up to 24 months ]
  • Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time [ Time Frame: Up to 6 weeks ]
  • Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time [ Time Frame: Up to 6 weeks ]
  • Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL). [ Time Frame: Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Louise Magat

(415) 502-1822Louise.Magat@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Louise Magat

(415) 502-1822Louise.Magat@ucsf.edu

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Zhen Wang, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-11-12.